To understand the immunogenicity of Covisheild vaccine in patients with rheumatological disease by discontinuing methotrexate temporarily after taking second dose of vaccine
- Registration Number
- CTRI/2021/07/035307
- Lead Sponsor
- Centre for Arthritis and Rheumatism Excellence CARE
- Brief Summary
*EffectOf Discontinuationof Methotrexate,post 2nd dose on Immunogenicity Of ChAdOx1 nCoV -19 Corona Virus (**COVISHIELD)**Vaccination in Patients With Autoimmune Rheumatic diseases who continued their Methotrexate doses after 1st dose : A Single Centre Randomized Clinical Trial***OBJECTIVE:** To investigatewhether temporary discontinuation of Methotrexate(MTX) for 2 week a fter second dose of Covishield vaccination improves the immunogenicity in patients with Autoimmune Rheumatic diseaseswho have continued Methotrexate after 1st dose.
we study the effect oftemporary discontinuation of MTX for 2 weeks post Covishield
vaccine doses on the humoral and cellular immunogenicity at the end of 1month post 2nd dose of vaccination.
.Objective
· To investigate whether temporarydiscontinuation of Methotrexate for 2 weeks after 2nd dose ofcovishield vaccination improves the immunogenicity in patients with AIRD whohad continued their Methotrexate doses after 1st dose.
· To see the effect of short termdiscontinuation of Methotrexate on AIRD disease activity.
**Outcomes**
· The anti spike/neutralisingantibody titrewill be assessed1 monthafter the second dose of vaccine, and will be compared between 2 groups whocontinued methotrexate after 2nd dose and other group whodiscontinued Methotrexate for 2 weeks post 2nd doseand to see ifthere is statistically significant difference among the two groups studied.
· Any significantchange in disease activity associated with discontinuation of methotrexate for2 weeks will be noted.
.Reference
1.Singh JA, SaagKG, Bridges SL Jr et al (2016) 2015 American College of Rheumatology Guidelinefor the treatment of rheumatoid arthritis. Arthritis Rheum 68(1):1–26
2.Smolen JS, Landewe R, Breedveld FC etal (2014) EULAR recommendations for the
management of rheumatoid arthritis withsynthetic and biological disease-modifying
antirheumatic drugs: 2013 update. AnnRheum Dis 73(3):492–509
3.Impact of temporary methotrexatediscontinuation for 2 weeks on immunogenicity of seasonal
influenza vaccination in patients withrheumatoid arthritis: a randomised clinical trial Park JK,
et al. Ann Rheum Dis2018;77:898–904. doi:10.1136/annrheumdis-2018-213222
4. Doran MF,Crowson CS, Pond GR, et al. Frequency of infection in patients with rheumatoidarthritis compared with controls: a population-based study. Arthritis Rheum2002;46:2287–93. 2 Au K, Reed G, Curtis JR, et al. High disease activity isassociated with an increased risk of infection in patients with rheumatoidarthritis. Ann Rheum Dis 2011;70:785–91.
5.Akkara VeetilBM, Bongartz T (2011) Perioperative care for patients with rheumatic diseases.Nat Rev Rheumatol 8(1):32–41
6.Tada M, InuiK, Sugioka Y, Mamoto K, Okano T, Kinoshita T, Hidaka N, Koike T (2016) Delayedwound healing and postoperative surgical site infections in patients withrheumatoid arthritis treated with or without biological disease-modifyingantirheumatic drugs. ClinRheumatol 35(6):1475–1481
7.Park JK,et al. Ann Rheum Dis 2018;77:898–904
8.Nived et al |
9. Effect ofshort-term methotrexate discontinuation on rheumatoid arthritis diseaseactivity: post-hoc analysis of two randomized trials JinKyun Park1 & MinJung Kim1 &Yunhee Choi2 & Kevin Winthrop3 &YeongWook Song1 &EunBong Lee1
10.MethotrexateHampers Immunogenicity to BNT162b2 mRNA COVID-19 Vaccine in
Immune-MediatedInflammatory DiseaseRebecca H. Haberman et al
11 .Methotrexate and glucocorticoids, but not anticytokine therapy, impair the immunogenicity of
a single dose of the BNT162b2 mRNACOVID19 vaccine in patients with chronic inflammatory
arthritis.SerenaBugatti et al
12 .The effect of methotrexate andtargeted immunosuppression on humoral and cellular immune
responses to the COVID 19 vaccineBNT162b2: a cohort study, Satveer k Mahil et al .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 230
- Inclusion Criteria Patient above 18 years of age.
- Patients willing to give consent for the study Patients with a prior diagnosis of Autoimmune Rheumatic Disease and on methotrexate , stable dose for atleast the past 2 months.
- Patients who had covid-19 infection in the past.
- Patients who are not willing for blood sample collection.
- Patients with h/o allergy to vaccine components Prior GBS/demyelinating syndromes Any live vaccine taken within prior 4 weeks or inactivated vaccine in last 2 weeks before study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the immunogenicity of Covishield vaccination in patients with Auto immune Rheumatic Diseases on methotrexate discontinuation temporarily for 2 weeks after second dose of vaccine versus those who continued methotrexate, in patients who continued their methotrexate doses after 1st dose. To compare the immunogenicity of Covishield vaccination in patients with Auto immune Rheumatic Diseases on methotrexate discontinuation temporarily for 2 weeks after second dose of vaccine versus those who continued methotrexate, in patients who continued their methotrexate doses after 1st dose. To see the effect of short term discontinuation of Methotrexate on AIRD disease activity. To compare the immunogenicity of Covishield vaccination in patients with Auto immune Rheumatic Diseases on methotrexate discontinuation temporarily for 2 weeks after second dose of vaccine versus those who continued methotrexate, in patients who continued their methotrexate doses after 1st dose.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dr Shenoy’s Care Private Limited
🇮🇳Ernakulam, KERALA, India
Dr Shenoy’s Care Private Limited🇮🇳Ernakulam, KERALA, IndiaDr Padmanabha Shenoy DPrincipal investigator9446567000drdpshenoy@gmail.com